MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

September 13, 2012 updated by: InSightec

Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of > 50% on palpation, and >65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Many patients are now diagnosed with breast fibroadenomas. These are generally detected during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in the breast. These patients then go on to receive mammograms, sonograms and usually a core biopsy for the differential diagnosis of benign disease (fibroadenoma) vs breast cancer. Although fibroadenomas are benign, they can be of great concern to the patient because of their ability to mask the presence of other lumps in the breast, they can be painful, cause a physical deformity of the breast or have other symptoms. The current treatment is surgical excision. Surgical removal is invasive and may be cosmetically undesirable to some patients. It would be advantageous to develop a non-invasive ablative method for treatment of this disease. Measures of the clinical success of patients who elect surgical removal of fibroadenomas are generally subjective, and evaluated primarily by the patient (lack of palpable lesion, pain free, and an acceptable cosmetic result). A non-randomized study is proposed to allow for a more practical approach in subject recruitment. Analysis on safety and efficacy will be performed through the use of MRI evaluation and physical exams.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Miyazaki-ken, Japan, 880-0052
        • Breastopia Namba Hospital
  • United States
    • Florida
      • Boca Raton, Florida, United States, 33431
        • University MRI
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Virtua
    • New York
      • New York, New York, United States, 10022
        • Cornell Vascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gender: Females only
  • Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy.
  • Single tumor per breast quadrant
  • Tumor clearly visible on non-contrast MRI
  • Age > 18 years 3.2.6 Signed informed consent
  • Tumor 5 mm or larger as measured on pre-treatment MR.

Exclusion Criteria:

  • Gender: male
  • Focal breast lesion on MRI over 3.5 cm as evaluated by MRI
  • Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm.
  • Microcalcifications within the lesion
  • Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis.
  • Hemolytic anemia (hematocrit<30)
  • Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Severe hypertension (diastolic BP > 100 on medication)
  • Patients with cardiac pacemakers
  • ASA Score>2
  • Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 3.3.12 Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 3.3.13 Patients with breast implants
  • Large patients who cannot fit in the magnet (weight>250 pounds), and patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
  • Patients on anti-coagulation therapy, or those with an underlying bleeding disorder.
  • Patient has a prior history of breast cancer
  • Patient has a prior history of laser or radiation therapy to the target breast
  • Patient has a prior history of chemo therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
treatment/ablation of breast fibroadenoma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Investigators

  • Principal Investigator: Clare Tempany, M.D., Brigham and Women's Hospital
  • Principal Investigator: Robert Min, M.D., Cornell Vascular
  • Principal Investigator: Fred Steinberg, M.D., University MRI
  • Principal Investigator: Mark DeLaurentis, M.D., Virtua
  • Principal Investigator: Hidemi Furusawa, M.D., Breastopia Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BF002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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